Are you a compliance expert passionate about ensuring the highest standards in medical device manufacturing? A major Medical Firm, located in the thriving hub of Atlanta, GA, is seeking a Medical Device Manufacturing Compliance Manager to lead compliance initiatives and uphold regulatory standards across all manufacturing operations.
About the Firm:
This renowned firm is a leader in the medical device industry, dedicated to innovation and excellence in patient care. With a strong focus on maintaining regulatory compliance, they continuously strive to improve product quality and operational efficiency. As they expand their manufacturing capabilities, they are looking for a seasoned compliance manager to join their team and help shape the future of medical technology.
Responsibilities of the Medical Device Manufacturing Compliance Manager:
As the Medical Device Manufacturing Compliance Manager, you will be responsible for:
- Regulatory Compliance: Ensuring all manufacturing processes meet FDA, ISO, and other relevant regulatory standards.
- Audits and Inspections: Leading internal and external audits, preparing for inspections, and ensuring corrective actions are effectively implemented.
- Quality Systems Oversight: Managing quality management systems (QMS) to maintain product safety, efficacy, and regulatory compliance.
- Documentation and Reporting: Ensuring accurate documentation and timely reporting of compliance activities, including risk assessments and CAPA.
- Training Programs: Developing and delivering compliance training programs to ensure all staff are aware of and adhere to regulatory requirements.
- Cross-functional Collaboration: Working closely with manufacturing, quality assurance, and R&D teams to integrate compliance strategies into daily operations.
Qualifications:
To excel in the role of Medical Device Manufacturing Compliance Manager, candidates should have:
- Extensive Experience: Proven experience in regulatory compliance management within the medical device manufacturing industry.
- Certifications: Relevant certifications such as RAC, CQE, or similar are highly preferred.
- Knowledge of Regulations: In-depth knowledge of FDA regulations, ISO standards, and quality management systems.
- Leadership Skills: Strong leadership and communication skills, with the ability to guide cross-functional teams through compliance processes.
- Attention to Detail: A keen eye for detail, ensuring all compliance standards are met consistently.
How to Apply:
Are you ready to take on a key role in ensuring regulatory excellence in medical device manufacturing? Submit your resume and cover letter outlining your qualifications and vision for this role.
Join our dynamic team and play a critical part in delivering safe, innovative medical devices that improve patient lives.
